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Completed

NCT Number: NCT02289404

A Study to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203

The purpose of this study is to evaluate food effect on the pharmacokinetics of NVP-1203

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Key information

Conditions

Healthy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook National University Hospital

Daegu, Dongdeok-ro, 700-721, South Korea

About this study

This study is designed as randomized, open-label, crossover assignment for evaluate the food effect on the pharmacokinetics of NVP-1203 in healthy adult subjects

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy adult subjects who signed informed consent

Exclusion criteria

  • Subjects has a history of allergy reaction of study drug ingredient
  • Subjects participated in another clinical trial within 3 months prior to administration of the study drug
  • Inadequate subject for the clinical trial by the investigator's decision

Treatment and study plan

NVP-1203

Drug

Oral

Primary outcomes

  1. Pharmacokinetics : Cmax

    Time frame: 0-24 hours

    Maximum plasma concentration

  2. Pharmacokinetics : AUCt

    Time frame: 0-24 hours

    Area under the concentration-time curve

Secondary outcomes

  1. Pharmacokinetics : AUCinf

    Time frame: 0-24 hours

    AUC extrapolated to infinity

  2. Pharmacokinetics : Tmax

    Time frame: 0-24 hours

    Time to reach the Cmax

  3. Pharmacokinetics : t1/2

    Time frame: 0-24 hours

    Terminal elimination half-life

Sponsors and collaborators

Lead sponsor

NVP Healthcare

Industry

Registry information

Official study title

Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203 in Healthy Adult Subjects

Acronym: NVP-1203

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 13, 2014
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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